bryostatin 1 and cytarabine in treating patients with relapsed acute myelogenous leukemia

Conditions: Leukemia

Summary: rationale: drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. combining more than one drug may kill more cancer cells. purpose: phase ii trial to study the effectiveness of combining bryostatin 1 with cytarabine in treating patients who have relapsed primary acute myelogenous leukemia.

objectives: * determine the response rate in patients with primary acute myelogenous leukemia in first relapse treated with bryostatin 1 and high-dose cytarabine. * determine the toxic effects of this regimen in these patients. * determine the relapse-free survival and overall survival of patients treated with this regimen. outline: this is a multicenter study. * induction: patients receive bryostatin 1 iv over 24 hours on days 1 and 11. patients also receive high-dose cytarabine iv over 3 hours every 12 hours for 4 infusions on days 2-3 and days 9-10. patients who achieve a major response receive a second course of induction therapy. * consolidation: patients who achieve complete remission receive bryostatin 1 iv over 24 hours on days 1 and 10 and high-dose cytarabine iv over 3 hours every 12 hours for 2 infusions on days 2 and 9. treatment continues for up to 6 courses in the absence of disease progression or unacceptable toxicity. patients who achieve a response and subsequently relapse may receive additional induction and consolidation therapy at the discretion of the investigator. patients are followed every 6 months. projected accrual: a total of 15-46 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed primary acute myelogenous leukemia (aml) in first relapse after a remission of at least 3 months duration * no secondary aml, including the following: * therapy-related aml * aml arising from myelodysplastic syndromes or similar hematological conditions * no philadelphia chromosome or other evidence of a (9;21) translocation * ineligible for potentially curative allogeneic stem cell transplantation patient characteristics: age: * 18 and over performance status: * zubrod 0-2 life expectancy: * not specified hematopoietic: * not specified hepatic: * bilirubin no greater than 1.5 times upper limit of normal (uln) (patients with gilbert's disease or unconjugated hyperbilirubinemia may have bilirubin no greater than 3.0 mg/dl with conjugated bilirubin no greater than 0.5 mg/dl) * ast/alt no greater than 2 times uln renal: * creatinine no greater than 1.5 times uln pulmonary: * no clinically significant pulmonary disease other: * no clinically significant cytarabine-related cerebellar toxicity * no nonmalignant systemic disease that causes poor medical risk * no active, uncontrolled, serious infection * no medical condition that would preclude study participation * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * see disease characteristics * no prior allogeneic stem cell transplantation chemotherapy: * at least 2 weeks since prior systemic chemotherapy (24 hours for hydroxyurea) and recovered endocrine therapy: * not specified radiotherapy: * not specified surgery: * not specified other: * recovered from all prior therapy

Keywords: recurrent adult acute myeloid leukemia adult acute myeloid leukemia with t(8;21)(q22;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with 11q23 (mll) abnormalities adult acute myeloid leukemia with t(15;17)(q22;q12)